The present invention relates to a method for creating a database for electronic storage and management of contents recorded on a form (or application), a method for inputting data to the created database and a method for outputting the contents inputted to the created data base.
There is a database system as an information system for managing a large amount of information represented by values, characters and symbols. According to "PRINCIPLE OF DATABASE SYSTEM" published on 1985 by The Computer Society of Japan, the database system is structured and used on the basis of the following procedures:
(1) the definition of data structure, that is, so-called table definition in relational database; PA1 (2) the input of data for each record of a table; and PA1 (3) the use of a table having the values of records inputted therein.
On the other hand, a method for defining a data structure or inputting data by use of a graphical user interface (hereinafter abbreviated to GUI) is provided in connection with recent database systems.
For example, a Microsoft Access disclosed by "Access Ver. 2.0 Part 3", pp. 38-46 published on 1995 by AI Shuppan provides a method in which a display screen for inputting data to a database having a predefined data structure is generated in such a manner that parts called controls are arranged on the display screen. This control is defined as being an object on the display screen which a user operates by use of a GUI in order to cause the object to perform some operation (see Microsoft Press Computer Dictionary page 148 published on July, 1993 by ASCII Shuppan-kyoku). One of such controls includes a part representing an input/output area on which characters inputted by use of a keyboard can be displayed.
Also, in the case where a link is set by designating a position on a display screen by use of a cursor, a "Cursor Shape Setting Method" disclosed by JP-A-6-149532 exists as a technique of providing a cursor capable of surely designating a location where the link is to be set. This reference has disclosed a method in which the shape of a cursor is set in creating a correspondence between a map and a data entry included in a file.
A medical supplies company entrusts an investigator of a medical institution for the trial of newly developed and sale-expected investigative products for human beings. The entrusted investigator doses trial subjects with the investigative products to measure data of each trial subject in accordance with trial items. This is called a clinical trial. The result of the clinical trial is recorded on a recording form called case report form (hereinafter abbreviated to CRF). The trial items are prescribed for each investigative product which is the object of a trial. Information concerning the prescribed trial items is recorded on the CRF. The CRF has a printed form or an optically or electronically recorded form. In the following, the printed CRF will be called a CRF blank. Generally, the CRF blank is composed of a plurality of sheets for one investigative product. Namely, the CRF blank has trial items prescribed for each of several investigative products and several case records for each trial item are entered in the CRF blank.
On the basis of the CRF having case records entered therein, the medical supplies company summarizes the results of clinical trials by use of a database system so that the effectiveness of the investigative product is judged by use of the result of totalized data subjected to statistical processing, or the like. A database structured at this time (that is, a database having case records stored therein) is called a case record database. The case record database is structured in accordance with the following procedures.
(1) Trial items are prescribed for each investigative product and standard items are created depending upon the type of that investigative product. But, the contents or combination of items to be estimated differ for every investigative product.
(2) A CRF blank is created on the basis of the prescribed trial items.
(3) A table for inputting data recorded on the CRF blank is defined corresponding to a case record database. Namely, one (CRF) table is defined, for one kind of CRF, in the case record database.
(4) On the basis of the generated CRF table, there is generated a display screen for inputting the data recorded on the CRF blank to the case record database.
(5) The CRF blank created in the procedure (2) is distributed to an investigator who is a doctor. The result of the clinical trial is entered in the CRF blank. In the CRF blank is entered data (name, bodily temperature, blood pressure and so forth) in units of one trial subject. It is specified by the law that the doctor himself or herself makes an entry in the CRF blank and stamps the CRF with an approval seal.
(6) Data recorded on the filled CRF blank collected by the medical supplies company is inputted to the case record database by use of the display screen generated in the procedure (4). Data recorded on the same kind of CRF blank is inputted to the same CRF table.
(7) The case record database having the results of the clinical trial inputted thereto in the procedure (6) is searched (or referred to) for data of individual trial subjects in order to judge the effectiveness or the like of the investigative product.
Though the above-mentioned prior art has described the generation of a display screen for inputting data to a database for which a data structure is predefined, this prior art is silent for the generation of a display screen for inputting data to a database for which a data structure has not yet been defined. Therefore, the following problems arise in the case where a case record database is to be newly structured.
In the above-mentioned prior art, the input display screen is generated on the basis of a field name of the database. Therefore, it is necessary to designate a field name of the database when the display screen for the input of data to the database is to be generated. Accordingly, a work for distinguishing unnecessary field names in order to input data recorded on a form is required, thereby deteriorating the working efficiency of a case record database creating work.
Also, since a positional relationship in a form between cells filled with data to be inputted to the database is different from that on the input display screen between input areas for inputting the data, the working efficiency of an inputting work is deteriorated.
Further, the above-mentioned prior art is silent for a database creating method suitable in creating another case record database concerning a CRF including trial items similar to those in a CRF for which a case record database has already been created and is also silent for a method of managing standardized trial items. Therefore, the working efficiency of the case record database creating work is deteriorated, thereby increasing the time required for creating the case record database.
Furthermore, the above-mentioned prior art has referred to a function of changing an input display screen for inputting a predefined data structure, but is silent for a function of changing the data structure in accordance with the change of the input display screen. Therefore, the working efficiency of the case record database creating work is deteriorated, thereby increasing the time required for creating the case record database.